Model Number EP003994S |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a radiofrequency procedure, the needle had scraped the lumen of the catheter.The needle was replaced with a competitor needle with resolve.The case was completed with radiofrequency.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the needle, ep003994s with lot number 212174649, was returned and analyzed.The needle was visually inspected, and no anomaly was noticed.In conclusion, the reported skiving issue was not confirmed.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the transseptal needle, (b)(4) with lot number 212174649, was returned and analyzed.Visual inspection of the needle showed that no issue was identified.The reported skiving issue was not confirmed through visual inspection of the product.However, it is plausible that skiving occurred as there is a compatibility issue with the needle and a competitor sheath.The cause of the issue was not established.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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